ACC: Policymakers can rest assured about safety of PCI without surgical backup
The CPORT-E trial was designed to assess the safety and efficacy of performing elective PCI in hospitals without cardiac surgery backup. Until the most recent 2011 guidelines, the ACC and the American Heart Association had recommended that hospitals without cardiac surgery capabilities handle only emergency PCI and transfer elective PCI patients to hospitals with onsite cardiac surgery.
In the trial, 18,867 patients were randomly assigned to receive either elective PCI at a facility with on-site cardiac surgery (4,718 patients) or a community hospital without onsite cardiac surgery (14,149 patients). The endpoints were six-week mortality and nine-month incidence of major adverse cardiac events (MACE), which included the composite of death, Q-wave MI or target vessel revascularization.
To qualify for the trial, hospitals underwent in a development program and were required to demonstrate that they could perform at least 200 PCIs annually. Sixty community hospitals participated in the study.
At six weeks, the mortality rate was 0.9 percent at hospitals without backup compared with 1 percent at hospitals with cardiac surgery units. The nine-month MACE rates were 12.1 percent for the hospitals without cardiac surgery backup compared with 11.2 percent at the hospitals with cardiac surgical backup. “Mortality at six weeks was the same at hospitals with or without cardiac surgery on site,” Aversano said. MACE rates at nine months were also similar, he noted.
The researchers observed some differences between the two groups, he continued. The rate of target vessel revascularization was higher at the hospitals without cardiac surgery units, at 6.5 percent vs. 5.4 percent. Hospitals without cardiac surgery units on site had a higher rate of bare-metal stent use (24.2 percent vs. 22.9 percent).
Hospitals with on-site cardiac surgery had a lower rate of staged PCI procedures (26.1 percent vs. 68 percent) and performed CABG more frequently (2.3 percent vs. 1.5 percent).
“Potential reasons for the difference in TVR for hospitals without onsite cardiac surgery may include a higher rate of bare-metal stent use, a more conservative approach for PCI because of the absence of backup surgery or procedural performance in a relatively inexperienced institution or lack of a full complement of interventional devices such as atherectomy devices or intravascular ultrasound,” Aversano said.
“In conclusion, in hospitals without onsite cardiac surgery that participated in a formal PCI development program, adhered to CPORT requirements and had outcomes monitored, the outcomes of primary PCI are non-inferior to outcomes in hospitals with surgery on-site,” he said.
Panelist Robert A. Harrington, MD, director of the Duke Clinical Research Institute in Durham, N.C., asked how widely should the practice of hospitals without cardiac surgery backup be applied across the country. In response, Aversano explained that the purpose of the study was not to support the concept than PCI should be expanded to as many hospitals as possible.
Rather it was designed to help inform healthcare regulators, policymakers and national organizations. “Is it possible? Is it safe? “What are the bounds at which it is safe?” he explained.
Aversano later reiterated that point at a press conference. “The purpose of the study was to answer the question whether healthcare planners can use this angioplasty without onsite cardiac surgery as a tool. Is it an option?” Aversano asked. “This study says, yes it is an option.”
Results of the study were simultaneously published March 25 in the New England Journal of Medicine.